A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Trial Profile

A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2018

At a glance

  • Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Dynavax Technologies
  • Most Recent Events

    • 05 Apr 2018 Results assessing safety of hepatitis B vaccine by using data from three phase III studies including this study published in the Vaccine.
    • 27 Dec 2017 Results assessing immunogenecity published in the Vaccine.
    • 09 Nov 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
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